Decorative Contact Lenses: Truly Frightening

The View From the FDA

Editor's Note:Decorative, noncorrective contact lenses have become the latest must-have accessory for many young adults; they allow someone's eye color to match their outfit or add the perfect touch to a Halloween costume. However, these lenses are actually medical devices regulated by the US Food and Drug Administration (FDA). Unfortunately, non-FDA-approved/cleared devices abound and can be purchased from street vendors and beauty supply stores, or online. According to the American Optometric Association's 2012 American Eye-Q® consumer survey, 18% of those surveyed reported use of these products.

Both patients and clinicians may be unaware of the potential dangers of these products. In addition, clinicians may not recognize the need to query patients whom they are evaluating for eye complaints about their use of these products, and patients may not volunteer this information. Medscape interviewed Michelle Tarver, MD, PhD, an ophthalmologist and epidemiologist in the Office of Device Evaluation at the FDA, about the growing use of these products and the important information clinicians need to know.

Medscape: Can you provide an overview of these products? Who uses them? How many people use them?

Dr. Tarver: Decorative, or cosmetic, contact lenses are also called "Halloween," "fashion," "theater," and "colored lenses." These lenses change the color or the perceived shape or appearance of the eye. Some of them also correct vision, but many are more of a fashion accessory and do not correct vision.

These lenses, like other contact lenses, require a prescription from an eye care provider even if they do not correct vision. The reason why this is required is because they are prescribed to fit a given patient's eye. They are not permitted to be sold over the counter.

As I said, many people wear them as a fashion accessory, which means that the wearer has not been fitted by an eye care provider and has not been trained in how to wear or care for the lenses. The primary consumers of these lenses are young adults, teens, and tweens. We primarily receive reports of adverse events in young adult women or teenage girls. Although we do not think that they are the sole utilizers of these devices, this is the group in which most of the adverse events reported to us occur.

There are also certain groups that tend to wear these lenses more frequently, including people involved in costume play or the gothic, anime, or comic subcultures. Finally, there are seasonal increases in the use of these lenses around Halloween and during the release of certain movies, such as Twilight and The Hunger Games.

Because many of the lenses used are not sold legally, we don't really know how many people use them. We do have marketing information for devices that are cleared or approved, but we often do not have that information for some of these decorative contact lenses.

We do know that there are many, many Websites selling them, and we know that many local vendors are dispensing them -- often illegally, unfortunately. Vendors include beauty supply stores, salons, flea markets, gas stations, convenience stores, tanning salons, tattoo parlors, and mall kiosks.

Medscape: How do FDA-approved/cleared products differ from products that are not?

Dr. Tarver: Most decorative contact lenses are daily-wear soft contact lenses and are regulated as class II devices via the 510(k) pathway under special controls. That means that before being cleared for marketing, these products have to meet mandatory performance standards for toxicology, biocompatibility, and microbiology and have an engineering design that has been shown to be safe. These lenses are also subject to postmarketing surveillance.

The manufacturing processes and the material composition of products that have not been cleared or approved by the FDA are unknown. Because they have not been reviewed by the FDA, their safety profile is unclear, and they may pose an increased risk for poor outcomes to the wearer. There are several brands of decorative lenses that have gone through the appropriate process to be cleared.

Medscape: What types of adverse events may occur with unregulated products? Are you able to estimate the percentage of events that are attributable to the use of these products?

Dr. Tarver: Unfortunately, we don't know the actual number of adverse events because many are not reported to the FDA. The injuries that can occur with decorative contact lenses include painful red eyes associated with cuts or scratches to the top layer of the cornea. Allergic reactions and serious, sight-threatening infections of the eye can also occur.

Most of the reports we get are voluntary reports from either providers or consumers, and we have not received a lot for these devices. Consumers may not be aware of the MedWatch reporting mechanism at the FDA. Manufacturers also have a reporting requirement. For lenses that are not cleared or approved, it is fairly clear why those manufacturers would not report adverse events.

Medscape: Are the adverse events associated with these products a result of manufacturing problems, improper fit, or poor care?

Dr. Tarver: We think all of the above. When contact lenses are prescribed, patients undergo a fitting regimen to make sure that the lens is situated correctly on the eye. They are also taught how to put them in, how to remove them, and how to care for them.

Patients who buy decorative contact lenses from unauthorized vendors clearly are not receiving this type of fitting or instruction. We think that the absence of care instructions is an important factor in the development of adverse events. How the colors are applied to the lens and the materials used to make the lens may also affect the adverse event profile, but we just do not have a way of knowing because we lack that information.

Medscape: Which are the most serious of these events and warrant referral to an eye care professional?

Dr. Tarver: I want to emphasize that all eye complaints that present to a primary care provider should be referred to an eye care professional, particularly if the patient is using any type of ophthalmic device, such as a contact lens.

Similar to other contact lenses, the most visually devastating complication of decorative contact lenses is microbial keratitis. A study performed by a French group found that decorative contact lens wearers have a 5-fold higher odds of developing microbial keratitis than other soft contact lens wearers.[1] Given that the estimated annualized incidence of microbial keratitis in contact lens wearers is 4 per 10,000 persons,[2] you can see that this could be a significant hazard, particularly in our young people.

The rate of microbial keratitis associated with decorative contact lenses in the United States is unclear, as is the rate of use of decorative lenses overall. Unfortunately, we just do not have the information. We have been requesting providers to please report any adverse events that they experience with these lenses to us, so that we can get a better idea of the burden of this problem in our population.

Medscape: Is there any information about the spread of serious infections as a result of shared use of contact lenses?

Dr. Tarver: Several small studies have looked at hygiene practices and sharing lenses, but they have not allowed us to make precise estimates about the impact of sharing on infection rates. Other hygiene factors are also significant risk factors for developing infection -- such behaviors as licking lenses before putting them in if they fall out of the eye, using water to clean the lenses, or wearing a lens beyond the prescribed timeframe for wear. We presume that these factors also affect wearers of decorative lenses.

Medscape: Primary care providers have too little time and too much information to convey during patient visits. What pointers can you give providers to help them target the right patients and to appropriately query patients about their use of decorative contact lenses?

Dr. Tarver: The primary wearers of these lenses tend to be tweens, teens, and young adults -- so pediatric, family medicine, and emergency department personnel are most likely to see them. Posters and other materials that educate potential wearers may be particularly useful in emergency departments.

It is very difficult with the visit lengths typical in primary care to cover all of the things that need to be covered in a visit. However, if the patient comes in reporting any ocular problems or a desire to wear contact lenses, the provider should then point them in the direction of an eye care provider to properly inform and teach them about the use of these devices as well as to properly fit them for the devices.

Medscape: What should providers tell patients who may wish to use these products?

Dr. Tarver: Clinicians should be sure that patients know that these lenses are medical devices and they do carry risks, and one of the more severe risks is blindness. They should refer any patient who is interested in wearing new lenses to an eye care provider who can properly fit them for the lenses and teach them the appropriate care for those lenses. There are legally marketed lenses that can help patients achieve the look that they may be trying to accomplish.

These are the major take-home points:

Don't share lenses;

Only obtain these products from an eye care provider who can fit them appropriately.

Public Information from the FDA and Medscape
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